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Active, not recruitingNCT06180239Updated Dec 22, 2023

Segmentectomy vs Lobectomy

An observational study in Non-small Cell Lung Cancer Stage I and Surgery, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-22.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
800
Ages
18 Years and older
Sex
All
01

Study summary

Actual indications for stage Ia NSCLC patients suggest lobectomy and lymphadenectomy. On the other hand, recent studies reported non-inferiority of segmentectomy in case of nodule \< 2cm or with ground glass appearance at computed tomography.

However, most of these studies did not report specifical analysis on kind of segmentectomy (single or multiple) and kind of lobectomy. Moreover, a specific study on solid nodules only is still missing.

For these reasons, the effectiveness of segmentectomy instead lobectomy for every kind of segment or tumor is still to be defined.

Aim of this study is to analyze survival outcome in patients underwent single or multiple segmentectomy compared to lobectomy in stage I non small cell lung cancer.

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Conditions studied

  • Non-small Cell Lung Cancer Stage I
  • Surgery

Keywords

  • segmentectomy
  • lobectomy
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In context

Carcinoma, Non-Small-Cell Lung

6,485 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.

This study's planned enrollment of 800 is above the median of 161 across 948 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients affected with NSCLC solid or part solid at the CT scan or PET CT study. These patients underwent anatomical resection with lymphoadenectomy and radical intent

Inclusion criteria

  • Adenocarcinoma or squamous cell carcinoma
  • cStage cIA with or without nodal upstaging
  • lymphoadenectomy
  • age > 18 years old
  • Radical resection
  • anatomical resection (lobectomy or segmentectomy)
  • PET CT done

Exclusion criteria

Exclusion Criteria:

  • Nodal or distant metastasis confirmed before surgery
  • Pure solid GGO
  • Follow up \< 12 months
  • Bilobectomy/pneumonectomy
  • Trans fissure tumor
  • Multiple lung tumors
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
800 participants (estimated)
Patient registry
No

Groups and cohorts

  • Single Segmentectomy group

    patients underwent single segment resection,

  • Lobectomy group

    Patients underwent lobectomy

  • Multiple segmentectomy group

    patients underwent multiple segments resection,

06

What researchers measure

Primary outcomes

  1. disease free survival

    Time between surgery and recurrence appearance

    Time frame: 1 YEAR

07

Study locations

1 site
  • Marco Chiappetta
    Roma, 00168, Italy
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References and documents

Publications

  • Postmus PE, Kerr KM, Oudkerk M, Senan S, Waller DA, Vansteenkiste J, Escriu C, Peters S; ESMO Guidelines Committee. Early and locally advanced non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017 Jul 1;28(suppl_4):iv1-iv21. doi: 10.1093/annonc/mdx222. No abstract available. PubMed 28881918 ↗
  • Saji H, Okada M, Tsuboi M, Nakajima R, Suzuki K, Aokage K, Aoki T, Okami J, Yoshino I, Ito H, Okumura N, Yamaguchi M, Ikeda N, Wakabayashi M, Nakamura K, Fukuda H, Nakamura S, Mitsudomi T, Watanabe SI, Asamura H; West Japan Oncology Group and Japan Clinical Oncology Group. Segmentectomy versus lobectomy in small-sized peripheral non-small-cell lung cancer (JCOG0802/WJOG4607L): a multicentre, open-label, phase 3, randomised, controlled, non-inferiority trial. Lancet. 2022 Apr 23;399(10335):1607-1617. doi: 10.1016/S0140-6736(21)02333-3. PubMed 35461558 ↗
  • Okada M, Yoshikawa K, Hatta T, Tsubota N. Is segmentectomy with lymph node assessment an alternative to lobectomy for non-small cell lung cancer of 2 cm or smaller? Ann Thorac Surg. 2001 Mar;71(3):956-60; discussion 961. doi: 10.1016/s0003-4975(00)02223-2. PubMed 11269480 ↗
  • Schuchert MJ, Pettiford BL, Keeley S, D'Amato TA, Kilic A, Close J, Pennathur A, Santos R, Fernando HC, Landreneau JR, Luketich JD, Landreneau RJ. Anatomic segmentectomy in the treatment of stage I non-small cell lung cancer. Ann Thorac Surg. 2007 Sep;84(3):926-32; discussion 932-3. doi: 10.1016/j.athoracsur.2007.05.007. PubMed 17720401 ↗
  • Suzuki K, Saji H, Aokage K, Watanabe SI, Okada M, Mizusawa J, Nakajima R, Tsuboi M, Nakamura S, Nakamura K, Mitsudomi T, Asamura H; West Japan Oncology Group; Japan Clinical Oncology Group. Comparison of pulmonary segmentectomy and lobectomy: Safety results of a randomized trial. J Thorac Cardiovasc Surg. 2019 Sep;158(3):895-907. doi: 10.1016/j.jtcvs.2019.03.090. Epub 2019 Apr 9. PubMed 31078312 ↗
  • Wiley JL, Balster RL. Antipunishment activity of diazepam in rats trained to discriminate diazepam from vehicle. Exp Clin Psychopharmacol. 1999 Feb;7(1):13-9. PubMed 10036605 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06180239
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborators
Regina Elena Cancer Institute, Istituto Europeo di Oncologia, University of Pisa, A.O.U. Città della Salute e della Scienza - Molinette Hospital, Azienda Ospedaliera "Sant'Andrea"
Responsible party
CHIAPPETTA MARCO (Dr, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Principal investigator
First posted
Dec 22, 2023
Start date
Jan 1, 2017
Primary completion
Dec 31, 2022
Completion
Dec 31, 2024 (estimated)
Last update
Dec 22, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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